Urethral catheterization is a routine procedure, which allows drainage of the bladder. Although the procedure is very common, catheter insertion may be difficult and may cause urethral injury. Traditional catheters currently used are generally blunt, difficult to insert, and are prone to damaging urethral walls. These problems are prevalent for both male and female patients and constitute a significant concern.
As evidenced by some reports, nearly 10% of male catheter insertions result in trauma requiring a urology consult and resulting in unnecessary operations. In males, the urethra is a narrow muscular tube that extends from the tip of the penis through the prostate into the bladder and is about 20-24 cm long and has a thin wall of about only 3 mm. Often, permanent damage is caused by the false passage of improper insertion. In many cases, a catheter cannot be properly placed in a male, necessitating delay while a consult is obtained. In males, the primary source of catheterization complications is due to enlarged prostate and pre-existing urethral strictures.
Catheterization in females may also be difficult and cause injuries. Females have small urethral openings through which insertion of a typical blunt catheter may be problematic. The procedure is often painful for the patients and difficult to perform for the medical practitioners. The common practice after encountering a difficulty inserting a catheter is continuing attempts by applying more force or using another similar blunt-tipped catheter. This often leads to unnecessary trauma.
One known method of inserting a catheter in problematic cases requires a dilation device. Existing dilation devices utilize guide wires for insertion. The dilation devices are used to expand the urethral lumen to allow for passage of a catheter. This procedure, however, has several significant shortcomings. The only commercially available devices use guide wires made of stiff metal, and therefore, frequently puncture patients' urethras. In addition, the complexity of these devices limits their utility because only licensed physicians are authorized to use them. In addition, urinary tract infection is a serious concern associated with catheters. Using dilation devices increases a patient's risk of urinary tract infection because the dilation device must be inserted and removed before the catheter may be inserted, thus increasing the likelihood of UTI.
Accordingly, there is a need for a urethral catheter with a flexible guide wire to facilitate a safer and easier catheterization. However, in view of the art considered as a whole at the time the present invention was made, it was not obvious to those of ordinary skill in the field of this invention how the shortcomings of the prior art could be overcome.
All referenced publications are incorporated herein by reference in their entirety. Furthermore, where a definition or use of a term in a reference, which is incorporated by reference herein, is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.
While certain aspects of conventional technologies have been discussed to facilitate disclosure of the invention, Applicants in no way disclaim these technical aspects, and it is contemplated that the claimed invention may encompass one or more of the conventional technical aspects discussed herein.
The present invention may address one or more of the problems and deficiencies of the prior art discussed above. However, it is contemplated that the invention may prove useful in addressing other problems and deficiencies in a number of technical areas. Therefore, the claimed invention should not necessarily be construed as limited to addressing any of the particular problems or deficiencies discussed herein.
In this specification, where a document, act or item of knowledge is referred to or discussed, this reference or discussion is not an admission that the document, act or item of knowledge or any combination thereof was at the priority date, publicly available, known to the public, part of common general knowledge, or otherwise constitutes prior art under the applicable statutory provisions; or is known to be relevant to an attempt to solve any problem with which this specification is concerned.